Arm
Conditions
Brief summary
This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.
Detailed description
Pediatric arm surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. Dexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses. This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus block using a local anesthetic at a fixed concentration. The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.
Interventions
infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg perineural dexamethasone
infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine with 0.1mg/kg intravenous dexamethasone
DRUG0.2ml/kg 0.2% ropivacaine
infraclavicular brachial plexus block with 0.2ml/kg 0.2% ropivacaine
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* children scheduled for arm/wrist/hand surgery * body weight \> 5kg
Exclusion criteria
* infection at the site of the regional block, * coagulation disorders, * immunodeficiency, * American Society of Anesthesiologists (ASA) physical status of IV or higher, * history of regular steroid medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first rescue opioid analgesia | 48 hours after surgery | Time to first rescue opioid analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | 48 hours after surgery | Total opioid consumption in milliequivalents of morphine |
| NRS | 4 hours after surgery | The numeric rating scale (NRS) with zero meaning no pain and 10 meaning the worst pain imaginable. |
| Nerve damage | 12 hours after surgery | Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome |
| NLR | 12 hours after surgery | Neutrophile-to-lymphocyte ratio |
| PLR | 12 hours after surgery | Platelet-to-lymphocyte ratio |
| glucose | 12 hours after surgery | blood glucose levels |
Countries
Poland
Contacts
Primary ContactMalgorzata Reysner, M.D. Ph.D.
Outcome results
None listed